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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CompoGuard Complete (NA) - 04086000860765

Device, Blood Mixing and Weighing
Fresenius Kabi AG
9029661
In Commercial Distribution

  • 04086000860765 ()
9029661

  • Blood donation rocker

CompoGuard Data (NA) - 04086000860758

Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029651
In Commercial Distribution

  • 04086000860758 ()
9029651

  • Blood donation rocker

CompoGuard Basic (NA) - 04086000860741

Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029641
In Commercial Distribution

  • 04086000860741 ()
9029641

  • Blood donation rocker

CompoMaster Net G5 - 04086000860581

The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.
Fresenius Kabi AG
9025571
In Commercial Distribution

  • 04086000860581 ()
9025571

  • Blood component separator, automated

CompoMat G5 - 04086000860475

The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems.
Fresenius Kabi AG
9025561
In Commercial Distribution

  • 04086000860475 ()
9025561

  • Blood component separator, automated

CompoDock - 04086000860215

The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Fresenius Kabi AG
9028721
In Commercial Distribution

  • 04086000860215 ()
9028721

  • Laboratory tubing welder

CompoMat G5 Plus - 04086000860161

The CompoMat G5/ CompoMat G5 Plus/ CompoMaster Net G5 Plus system is intended to be used as an automatic blood component separator for blood component separation and processing.
Fresenius Kabi AG
9026561
In Commercial Distribution

  • 04086000860161 ()
9026561

  • Blood component separator, automated

DXT Data Management System - 04086000101578

DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems.
Fresenius Kabi AG
3.0
In Commercial Distribution

  • 04086000101578 ()
X6S9830, X6S9830USB

  • Blood bank information system application software

Fenwal PLASMACELL-C Disposable Set - 04086000101455

For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Fresenius Kabi AG
4R2252
In Commercial Distribution

  • 04086000101455 ()
  • 14086000101452 ()
4R2252

  • Apheresis system tubing set

Fenwal AMICUS Double Needle Advanced Kit - 04086000101387

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354
In Commercial Distribution

  • 14086000101384 ()
  • 04086000101387 ()
4R2354

  • Apheresis system tubing set
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